The 6 Most Common Problems in FDA Software Validation and Verification

As manufacturing and quality systems rely more on software, exposure grows, and most recalls can be traced back to computerized equipment. This 120-minute FDA software validation webinar walks through the validation planning process, with a focus on avoiding six common problems.

You'll learn which data and systems fall under 21 CFR Part 11 and Annex 11, why compliance makes business sense, and how FDA requirements apply to software features such as security, audit trails and electronic signatures. The session also covers requirements for local, SaaS and cloud hosting.

After setting out the six most common problems in FDA software validation and verification, it explains strategies to avoid them, gives advice on staffing a validation project and shows how to reduce the risk of 483 observations and warning letters.

• Determine which data and systems fall under 21 CFR Part 11 and Annex 11
• Explain the business case for software validation compliance
• Apply FDA requirements for security, audit trails and electronic signatures
• Identify validation requirements for local, SaaS and cloud-hosted systems
• Recognize the six most common validation and verification problems and avoid them
• Staff a validation project for success and reduce the risk of 483s and warning letters

• Which data and systems are subject to 21 CFR Part 11 and Annex 11
• Why compliance makes good business sense
• FDA requirements for software features: security, audit trails and electronic signatures
• Requirements for local, SaaS and cloud hosting
• The 6 most common problems in FDA software validation and verification
• Strategies to avoid the most common problems
• Advice on staffing a validation project
• Avoiding 483s and warning letters

Many companies are unsure how to validate software to FDA standards, and that uncertainty often leads to inaction and wasted effort while the validation process faces more scrutiny. Knowing the usual mistakes in advance helps you plan with confidence.

This session suits system owners, computer system users, QA/QC and IT/IS managers and staff, validation specialists, software quality reviewers and consultants.

• System owners - responsible for keeping individual systems in validation
• Computer system users
• QA / QC managers, executives and personnel
• IT / IS managers and personnel
• Validation specialists
• Software quality reviewers
• Consultants

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.